CLEANer Aspiration for Pulmonary Embolism (CLEAN-PE)

April 1, 2026 updated by: Argon Medical Devices

A Prospective, Multicenter Study to Evaluate the Safety and Efficacy of an Aspiration Thrombectomy System in Acute Pulmonary Embolism

To evaluate the safety and efficacy of the Cleaner™ Pro Thrombectomy System for aspiration thrombectomy in patients with acute pulmonary embolism (PE).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
125

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Holly Harrison
  • Phone Number: 4697313561

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Medstar Health Research Institute
    • Florida
      • Tampa, Florida, United States, 33607
        • BayCare Health System
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Ascension St. Vincent Hospital
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • UMass Chan Medical School
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • University Medical Center of Southern Nevada
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Toledo, Ohio, United States, 43606
        • ProMedica Toledo Hospital
    • Oklahoma
      • Bartlesville, Oklahoma, United States, 74006
        • Ascension St. John Jane Phillips Medical Center
    • Texas
      • Dallas, Texas, United States, 75226
        • Baylor Scott and White Heart and Vascular Hospital - Dallas
      • Plano, Texas, United States, 75093
        • Baylor Scott & White The Heart Hospital - Plano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • At least 18 years of age at the time of consent
  • Clinical signs, symptoms, and presentation consistent with acute PE
  • Onset of PE symptoms occurred within 14 days of presentation
  • Filling defect in at least one main or lobar pulmonary artery evidenced by CTA
  • RV dysfunction on CTA or echocardiography defined as RV/LV ratio >0.9

Exclusion Criteria:

  • tPA use within 14 days prior to baseline CTA
  • Systolic BP <90 mmHg for 15 min or the requirement of inotropic support to maintain systolic BP ≥90 mmHg
  • Diagnosis of pulmonary hypertension primary type I or CTEPH; if patient does not have diagnosis of pulmonary hypertension but peak PA >70 mmHg by right heart catheterization or elevated main pulmonary artery to aorta ratio (MPA:A), up to investigator discretion.
  • History of severe or chronic pulmonary hypertension
  • FiO2 requirement >40% or >6 LPM to keep oxygen saturations >90%
  • Hematocrit <28%
  • Platelets <100,000/µL
  • Serum creatinine >1.8 mg/dL
  • INR >3
  • aPTT (or PTT) >50 seconds on no anticoagulation
  • History of heparin-induced thrombocytopenia (HIT)
  • Recent (within six months) history of stroke, transient ischemic attack (TIA), or intracranial bleeding
  • Recent (within one month) history of active bleeding from a major organ
  • Absolute contraindication to anticoagulation
  • Major trauma such as head trauma, or other active intracranial, or intraspinal disease within 14 days
  • Presence of intracardiac lead in the right ventricle or right atrium placed within 6 months
  • Cardiovascular or pulmonary surgery within last 7 days
  • Cancer which requires active chemotherapy
  • Known serious, uncontrolled sensitivity to radiographic agents
  • Life expectancy <90 days, as determined by investigator
  • Female who is pregnant
  • Intracardiac thrombus
  • Patients who present with cardiac arrest and/or are on extracorporeal membrane oxygenation (ECMO) or ECMO required to perform interventional procedure
  • Simultaneous participation in another investigational study
  • Patients with known coagulation disorders such as antiphospholipid, Protein C, and Protein S
  • Presentation of PE with paradoxical emboli which may be diagnosed by concurrent stroke or concurrent arterialization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mechanical Thrombectomy via Cleaner Pro
Participants will receive catheter-directed therapy via mechanical aspiration thrombectomy for the treatment of pulmonary embolism (PE) using the Cleaner Pro Thrombectomy System.
Device: Cleaner Pro Thrombectomy System
The Cleaner™ Pro Thrombectomy System ("Cleaner Pro") is a catheter-based aspiration thrombectomy device comprised of a handpiece, an aspiration catheter, a dilator, and an aspiration canister.
Other Names:
  • Cleaner Vac Thrombectomy System

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Right Ventricle (RV)/Left Ventricle (LV) Ratio
Time Frame: At 48 hours post-procedure
Change in RV/LV ratio between baseline and 48 hours post procedure assessed by CTA.
At 48 hours post-procedure
Rate of Major Adverse Events (MAEs)
Time Frame: At 48 hours post-procedure

Rate of MAEs within the first 48 hours after the index procedure, defined as:

Device-related death Major bleeding, and Device-related Serious Adverse Events which includes clinical deterioration, pulmonary vascular injury, and cardiac injury.
At 48 hours post-procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of device-related complications and device-related death
Time Frame: Within 48 hours of the procedure
Rate of device-related complications including major bleeding, clinical deterioration, pulmonary vascular injury, and cardiac injury, and device-related death within 48 hours of the index procedure.
Within 48 hours of the procedure
Rate of device-related SAEs and all-cause mortality
Time Frame: Within 30 days of procedure
Rate of device-related serious adverse events (SAEs) and death for any cause within 30 days post-procedure.
Within 30 days of procedure
Use of thrombolytics
Time Frame: Within 48 hours of the procedure
Use of thrombolytics within 48 hours of the procedure.
Within 48 hours of the procedure
Change in Modified Miller Index
Time Frame: At 48 hours post-procedure
Change in Modified Miller Index between baseline and 48 hours post-procedure assessed by CTA. This index score quantifies arterial obstruction in pulmonary embolism. The higher the score, the more perfusion is reduced.
At 48 hours post-procedure
Quality of Life assessed via PEmb-QoL
Time Frame: At 30 days post-procedure
Self-assessment of PE-related complaints and daily living limitations (including work and social). The PEmb-QoL measures 6 dimensions, with higher scores being worse.
At 30 days post-procedure
Quality of Life assessed via EQ-5D-5L
Time Frame: At 30 days post-procedure
Self-assessment of activities for daily living. The EQ-5D-5L measures 5 dimensions, with higher scores being worse.
At 30 days post-procedure
Rate of Symptomatic PE Recurrence
Time Frame: Within 30 days of the procedure
Rate of Symptomatic PE recurrence within 30 days.
Within 30 days of the procedure
Volume of blood aspirated
Time Frame: At index procedure
The amount of blood aspirated during the procedure.
At index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Argon Medical Devices

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
NAMSA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pete J Stibbs, MD, Argon Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 3, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 4, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 2, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 3, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CNPE01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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